Kornimate/medical-research-clean huggingface dataset:
68ga-thp-psma pet/ct in prostate cancer: clinical stage and restage

Conditions: Prostate Cancer

Summary: to evaluate the dosimetry, safety and the detection rate of 68ga-thp-psma pet/ct for identifying the site of prostate cancer metastasis and relapse. it is also to evaluate the association of clinical/pathologic features and 68ga-thp-psma pet/ct detection rate and compare 68ga-thp-psma pet/ct with other imaging procedure.


Eligibility criteria:
inclusion criteria: 1. adult male, age 18 years or older 2. prior diagnosis of prostatic cancer 3. willing to participate in this study and given written informed consent 4. ast, alt, bun, cr not more than double the normal values 5. subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment exclusion criteria: 1. subjects with pacemakers 2. hepatitis b virus infection (including carriers) at screening, i.e. hepatitis b surface antigen (hbsag) positive, or hepatitis c antibody (anti-hcv) positive, or acquired immunodeficiency disease (hiv) infected, or serum syphilis positive person 3. abnormal liver function during baseline screening period: ast or alt\> 2 times the upper limit of normal value (uln), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. once, if more than 2 times uln after retesting, consider enrolling). 4. impaired renal function during screening: serum creatinine or urea nitrogen \> 1.5 times uln. 5. within 4 months prior to the baseline screening period, myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above ii) 6. subjects with pulmonary embolism or deep vein thrombosis 7. various infections that the investigators consider unsuitable for study, including but not limited to patients with various infections requiring further treatment, such as urinary tract infections, respiratory infections, and diabetic foot infections. 8. patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or hashimoto's thyroiditis)

Keywords: 68ga-thp-psma pet/ct
role of nanoemulsified sesame oil in post-operative care after endoscopic sinus surgery

Conditions: Chronic Rhinosinusitis (Diagnosis)

Summary: the goal of our thesis is to design, develop and characterize a novel thermodynamically stable ne by spontaneous method intended for topical use. subsequently, appraisal of nanoemulsified sesame oil formulation has been performed on the post-operative symptoms in crs patients who have undergone ess (endoscopic sinus surgery) combined with different types of nasal irrigation which may affect formulation efficacy.


Eligibility criteria:
inclusion criteria: 1. patient age between 18 and 60 years old. 2. chronic rhinosinusitis patients who have undergone endoscopic sinus surgery. exclusion criteria: 1. patients with history of allergy for sesame seed derivatives. 2. patients with chronic diseases which affecting the process of healing (uncontrolled dm, renal failure and hepatic failure). 3. patients with nasal granulomas. 4. patients with invasive fungal rhinosinusitis. 5. smokers. 6. patients with history of radio and/or chemotherapy exposure. 7. patients with systemic diseases affecting integrity of nasal mucosa (e.g. cf, scleroderma, sjogren syndrome ...).
safety and efficacy of endoscopic full thickness biopsy in patients with chronic intestinal pseudo-obstruction

Conditions: Chronic Intestinal Pseudo-obstruction

Summary: to evaluate the safety and efficacy of endoscopic full thickness biopsy for the diagnostic purpose of chronic intestinal pseudo-obstruction.


Eligibility criteria:
inclusion criteria: * patients with chronic pseudo intestinal obstruction or suspected chronic pseudo intestinal obstruction * patients who are 18 years of age or older at the time of obtaining consent * gender: any exclusion criteria: * patients for whom it is difficult to perform endoscopy * patients who cannot obtain consent * patients with serious renal, hepatic, or cardiac disease * patients who are participating in other clinical research, except for observational research. * other patients whom the principal investigator or subinvestigator determines to be inappropriate to conduct this study.

Keywords: chronic intestinal pseudo-obstruction endoscopic full thickness biopsy
first-in-human study of m4076 in advanced solid tumors (ddriver solid tumors 410)

Conditions: Advanced Solid Tumors

Summary: the purpose of this study was to determine the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), maximum tolerated dose (mtd) (if reached) and early signs of efficacy of m4076 monotherapy in participants with solid tumors in dose escalation (part 1a). once the recommended dose for expansion (rde) was declared in part 1a, a preliminary food effect cohort, part 1b, will follow at the rde determined from part 1a.


Eligibility criteria:
inclusion criteria: * participants with advanced solid tumors, for whom no standard of care therapy exists or for whom is not considered sufficiently effective, or who cannot tolerate standard of care * participants with eastern cooperative oncology group performance status 0 or 1 * adequate hematological, hepatic, and renal function as defined in the protocol * participants in part 1b (the preliminary food effect assessment) must agree to provide paired tumor biopsies if not contraindicated for medical reasons * other protocol defined inclusion criteria could apply exclusion criteria: * clinically significant (i.e., active) uncontrolled intercurrent illness including, but not limited to: 1. active infection (i.e., requiring systemic antibiotics or antifungals) 2. uncontrolled arterial hypertension 3. severe cardiac arrhythmia requiring medication 4. cerebral vascular accident/stroke * has known ataxia telangiectasia * participants with tumors harboring previously identified atm mutations * participants with hypersensitivity to the active substance or to any of the excipients of m4076 * other protocol defined exclusion criteria could apply

Keywords: m4076 maximum tolerated dose pharmacokinetics pharmacodynamics
cyberknife radiosurgery for low & intermediate risk prostate cancer: emulating hdr brachytherapy dosimetry

Conditions: Prostate Cancer; Prostatic Cancer; Prostatic Neoplasms; Prostate Neoplasms; Cancer of the Prostate

Summary: the purpose of this study is to investigate the effects of cyberknife radiosurgery in patients with early stage organ-confined prostate cancer and to evaluate the effects of this treatment on the quality of life over time.

in this study, cyberknife radiosurgery will be used to produce dose distributions comparable to those created by high dose rate (hdr) brachytherapy treatment, without the use of invasive catheters. the radiosurgery volumes will closely be made to resemble hdr brachytherapy therapeutic volumes with similar dose limitation objectives to adjacent normal tissues. the cyberknife robotic radiosurgery system is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. the cyberknife system delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. this in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

Eligibility criteria:
inclusion criteria: * patient must be at least 18 years of age * histologically proven prostate adenocarcinoma * biopsy within 1 year of date of registration * clinical stage (cs) t1b-t2b, n0, m0 * patients belonging to one of the following risk categories: * low risk: cs t1b-t2a, gleason score 2-6, prostate specific antigen (psa) \< or = 10 ng/ml * intermediate risk: cs t2b, gleason score 2-6, psa \< or = 10 ng/ml or cs t1b-t2b, gleason score 2-6, psa \< or = 20 ng/ml or cs t1b-t2b, gleason score 7 and psa \< or = 10 ng/ml * eastern cooperative oncology group (ecog) performance status 0-1 exclusion criteria: * clinical stage t2c or greater * prior prostatectomy or cryotherapy of the prostate * prior radiotherapy of the prostate or lower pelvis * implanted hardware or other material that would prohibit appropriate treatment planning or delivery * history of an invasive malignancy other than basal or squamous skin cancers in the last 5 years * hormone ablation for two months prior to enrollment or during treatment

Keywords: prostate cancer cyberknife stereotactic radiosurgery radiosurgery prostate tumor prostate surgery
effects of carnitine supplementation on liver and muscle

Conditions: Non-Alcoholic Fatty Liver Disease; Insulin Resistance

Summary: it will be evaluated whether carnitine, a dietary supplement, reduces liver fat and improves metabolism in individuals who have a high concentration of fat within their liver. participants will be given either carnitine or placebo, together with a meal replacement milkshake twice daily for 6 months.

nafld occurs when too much fat accumulates in liver tissue. this can, over time, cause inflammation and scarring of the liver, eventually leading to chronic liver disease and cirrhosis. it is strongly associated with diabetes and obesity, both of which are endemic in western societies. carnitine enables cells in the body to use fat as a fuel, and recent studies have suggested that carnitine supplementation may reduce liver triglyceride content. muscle and liver are the major sites in the body which coordinate glucose and fat metabolism. as well as assessing the effect of carnitine supplementation on liver fat, its effect on metabolic processes within these tissues will also be measured

Eligibility criteria:
inclusion criteria: * elevated liver fat on screening abdominal ultrasound * capable of providing informed consent * non-vegetarian diet * bmi \<40 kg/m2 * weekly ethanol consumption \<21 units/week * negative non-invasive liver screen, including hepatitis b and c serology, liver autoantibodies, transferrin saturation, α1-antitrypsin levels. exclusion criteria: * known history of cardiovascular disease * known diabetes mellitus * known psychiatric comorbidity * chronic kidney disease * surgery within 6 months prior to start of study * exposure to drugs known to influence hepatic steatosis (including steroids, statins, omega-3-fatty acids) * current smokers * contraindications to magnetic resonance scanning, including implanted ferrous material (implantable pacemakers or defibrillators), metallic ocular foreign bodies, ferromagnetic aneurysm clips or severe claustrophobia.
the effects of exercise and probiotics on dysmenorrhea and microbiome

Conditions: Dysmenorrhea; Inflammation; Microbial Substitution

Summary: the study try to investigate the possible effects of exercise and probiotics supplementation on dysmenorrhea amelioration from the perspective of microbiome.

in current study, there were two stages designed for current study. the definition of dysmenorrhea population depended on the visual analogue scale (vas) of mcgill pain questionnaire (more than 5) and the vas score less than 2 was considered as non-dysmenorrhea population. in the first stage, the 20 subjects were recruit for non-dysmenorrhea group (control group) and other 60 subjects were randomly allocated into three group with original lifestyle, aerobic, and resistant exercise intervention (dys-control, dys-aerobic, and dys-resistant groups). the questionnaires (premenstrual syndrome, the menstrual distress, and mcgill pain), body composition, physical fitness, biochemistries, inflammation, hormones and microbiome analysis (feces and tampon) were evaluated and assessed before and after 10-weeks indicated exercise training. in the second stage, one hundred subjects (20 non-dysmenorrhea and 80 dysmenorrhea populations) will be recruited and the dysmenorrhea will be randomly allocated into dys-control, dys-probiotics, dys-exercise and dys-probiotics and exercise groups. the questionnaires (premenstrual syndrome, the menstrual distress, and mcgill pain), body composition, physical fitness, biochemistries, inflammation, hormones and microbiome analysis (feces and tampon) were evaluated and assessed before and after 10-weeks indicated interventions (probiotics and exercise).

Eligibility criteria:
inclusion criteria: * primary dysmenorrhea * visual analog score of mcgill pain questionnaire (0-2 for non-dysmenorrhea; \>5 for dysmenorrhea) exclusion criteria: * pregnancy, menstrual disorders, obesity (bmi\>30), smoking, and alcohol or drug addiction * cardiovascular disease, hypertension, diabetes, asthma, chronic pulmonary obstruction, mental illness

Keywords: lactobacillus sport nutrition
multicentre gmk uni anatomical cementless study - fr

Conditions: Osteoarthritis of the Knee; Avascular Necrosis of the Femoral Condyle; Revision Surgery

Summary: unicompartmental knee arthroplasty (uka) is the principal surgical alternative to total knee arthroplasty (tka) in patients with end-stage unicompartmental tibiofemoral osteoarthritis (oa) of the knee. the current post-marketing surveillance study aims to monitor gmk-uni monocompartmental knee prosthesis performances over a 10-year time period.


Eligibility criteria:
inclusion criteria: * patients presenting with disease that meets the indications for use for medacta implants included in this study (on-label use); * patients who are willing and able to provide written informed consent for participation in the study. written informed consent must be obtained prior to the patient's surgery; * patient's age between 18 and 75 years old; * patients must be willing to comply with the pre and postoperative evaluation schedule. exclusion criteria: * patients with one or more medical conditions identified as a contraindication defined by the labelling on any medacta implants used in this study; * any patient who cannot or will not provide informed consent for participation in the study; * patients who need a revision surgery * patients unable to understand and take action; * any case not described in the inclusion criteria; * patients aged under 18 years; * patients aged over 75 years;
marijuana use, strength training, and alcohol consumption (mustac) study

Conditions: Chronic Pain

Summary: self-medication of pain by consuming alcohol and marijuana is common. however, the research regarding pain as a determinant for alcohol and marijuana use has relied on laboratory pain induction paradigms with limited clinical relevance. the study will assess demand for alcohol and marijuana before and after delayed onset muscle soreness (doms) induction in co-users. this will provide a clinically relevant, but time-limited, model for the effects of musculoskeletal pain on demand.


Eligibility criteria:
inclusion criteria: * age ≥ 21 years; * english-speaking * self-identify as white/caucasian or black/african american * own a smartphone with cellular/data plan * regularly co-use alcohol and smoked marijuana as indicated by scores of ≥3 on item 1 of the cudit-r and audit. * willing and able to give informed consent exclusion criteria: * participation in biceps-specific conditioning program in the past 6 months\* * self-reported wrist/hand, elbow, or shoulder pain the past 3 months * chronic medical condition that may affect pain perception (e.g. diabetes, fibromyalgia, headaches) * self-reported kidney dysfunction, muscle damage, or major psychiatric disorder * medical marijuana prescription * consumption of marijuana using only non-inhalational methods (e.g. edibles, tinctures, or cannabidiol oil) * score of ≥ 10 on patient health questionnaire-9 (moderate depression) * women who are pregnant, trying to become pregnant, or breastfeeding
bupropion and restless legs syndrome

Conditions: Restless Legs Syndrome

Summary: the purpose of this study is to determine if bupropion will improve the symptoms of restless legs syndrome (rls).

adult patients with moderate to severe rls will be recruited for the study. those on medications which treat rls will be asked to discontinue the medications for two weeks prior to beginning the study. all participants will be screened with beck depression inventory, international restless legs syndrome study group (irlssg) severity scale, and clinical global impression of improvement (cgi-i) scale. an ordinal scale (i.e. rate symptoms from 1-8) will also be obtained. participants will be randomized to a placebo or medication group. those in the medication group will be given 150 mg of bupropion at night for six weeks. others will receive similar-appearing placebo. participants will be called at the end of weeks one, two, four and five to assess symptom severity based on irlssg scale, and to determine if they are experiencing any adverse effects. at three weeks and six weeks, participants will return to the clinic to complete all four of the initial forms, the beck depression inventory, irlssg severity scale, ordinal scale, and cgi-i.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of restless legs syndrome * severity scale score 15 or higher exclusion criteria: * history of seizures * history of alcohol use greater than 2 drinks per day or occasional binges of 5 or more drinks per day * suicidal thoughts/ideations * inability to return for follow up appointments at 3 and 6 weeks * lack of access to telephone * eating disorder * age less than 18 * pregnancy * unwillingness or inability to discontinue any rls medications

Keywords: restless legs syndrome bupropion
study for validation of target therapy in multiple myeloma cells from patients with mirnas released from b cells, and study of the bone marrow tumor microenvironment (microenvironment of mm)

Conditions: Multiple Myeloma

Summary: multiple myeloma (mm) is a hematologic cancer caused by the selective clonal expansion of plasma cells. by acting on the microenvironment of the bone marrow, mm shifts the niche balance and becomes chemoresistant due to its interaction with stromal cells. despite new therapeutic strategies, mm still remains incurable and new strategies are urgently needed. in order to successfully act on mm, we must use a strategy that reflects its plasticity and blocks it on several targets: proliferation, interaction with the microenvironment, and metastasis. the main interest of the project is to evaluate the effect of gene therapy identified in vitro, directly on patient-derived samples, in particular to translate the knowledge gained on myeloma cell lines in vitro to primary tumor cells taken from patients.

multiple myeloma (mm) is a hematologic cancer caused by the selective clonal expansion of plasma cells. by acting on the microenvironment of the bone marrow, mm shifts the niche balance and becomes chemoresistant due to its interaction with stromal cells. despite new therapeutic strategies, mm still remains incurable and new strategies are urgently needed. in order to successfully act on mm, we must use a strategy that reflects its plasticity and blocks it on several targets: proliferation, interaction with the microenvironment, and metastasis. the main interest of the project is to evaluate the effect of gene therapy identified in vitro, directly on patient-derived samples, in particular to translate the knowledge gained on myeloma cell lines in vitro to primary tumor cells taken from patients.

Eligibility criteria:
inclusion criteria: * age≥18 years; * diagnosis of multiple myeloma for which a bone marrow biopsy is scheduled for practice * patients able to express appropriate consent to participation in the study (e.g., able to understand italian, patient with intact cognitive abilities). exclusion criteria: * absence of signed informed consent form * inadequate or insufficient bone marrow biopsy material
performance and safety of the innofix® screw (if25)

Conditions: Pathologic Fracture

Summary: the purpose of this clinical investigation is to collect data about the safety and the performances of the innofix® screw : clinical performances (pain reduction due to the fracture treatment, maintenance of the stabilizaton of the treated fracture and mobility improvement) / technical performances (percutaneous implantation by mini-invasive approach, efficiency of percutaneous implementation and efficiency of percuatneous cementing) / safety performances (preservation of the screw stability after implantation and preservation of the screw integrity after implantation). the safety and performance data about the innofix® screw will be used to obtain their ce marking according to the regulation (eu) 2017/745. the principal objective of this clinical investigation is to assess the postoperative reduction in pain level of the patient at 6 weeks follow-up.


Eligibility criteria:
inclusion criteria: * the patient is 18 years old or more * the patient is a cancer patient * the patient needs a stabilization of a non-displaced pathologic fracture (complete or impending) of the pelvic bone * the patient is symptomatic with musculoskeletal pain exacerbated during movement or weight bearing * the patient has been informed and he has signed the informed consent * the patient must be willing and able to comply with all study requirements including follow-up visits and radiographic assessments * the patient is affiliated with the french social security system exclusion criteria: * the patient has got a displaced fracture or an unstable fracture justifying conventional surgical fixation * the patient is a pregnant woman or considered getting pregnant during its investigation participation * the patient presents medical conditions that could have an impact on the clinical investigation (under responsibility of the investigator) * the patient has got one or more contraindications to general anaesthesia * the patient has got an insufficient bone strength (severe osteoporosis, local infection, or tumor osteolysis) precluding a correct and long-term fixation * the use of the innofix® screw can interfere with anatomical structures or physiological performances * the patient has got an insufficient tissue coverage at the surgical site * the patient has got a sepsis, fever, subcutaneous or cutaneous infection on the implantation way, deep abscess in contact with the fracture site * the patient has got a mental or neuromuscular disorder that may cause fixation failure or postoperative complications * the patient is allergic and/or hypersensitive to a component of the innofix® modules, of the innotool™ instruments and to the used cement * the patient has got a haemostasis disorder ((inr \>1.5, platelets \<50x109/l) * the patient participates to another clinical investigation * the patient's life expectancy is lower than 6 months * the patient is under guardianship, curatorship or legal protection * the patient is deprived of liberty by a judicial or administrative decision

Keywords: fics pelvis cancer